Early human safety study of turmeric oil (Curcuma longa oil) administered orally in healthy volunteers.

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dc.contributor.authorJoshi, Jayashreeen_US
dc.contributor.authorGhaisas, Sadhanaen_US
dc.contributor.authorVaidya, Ashoken_US
dc.contributor.authorVaidya, Ramaen_US
dc.contributor.authorKamat, D Ven_US
dc.contributor.authorBhagwat, A Nen_US
dc.contributor.authorBhide, Sumatien_US
dc.date.accessioned2003-11-21en_US
dc.date.accessioned2009-05-30T20:12:19Z
dc.date.available2003-11-21en_US
dc.date.available2009-05-30T20:12:19Z
dc.date.issued2003-11-21en_US
dc.description.abstractOBJECTIVE: Turmeric extract and turmeric oil have shown chemoprotective effect against chemically-induced malignancies in experimental animals. They can reverse precancerous changes in oral submucous fibrosis in humans. The use of turmeric or Curcuma longa Linn as a spice and household remedy has been known to be safe for centuries. In view of the long term administration required for cancer prevention a Phase I clinical trial of turmeric oil (TO) was designed to study the safety and tolerance of TO in volunteers for a period of 3 months. MATERIAL AND METHODS: Nine healthy volunteers between 20 and 33 years of age were tested for haemoglobin, blood counts, liver and kidney functions, bleeding and clotting time and serum electrolytes initially and at 1 and 3 months of treatment. They were administered 0.6 ml of TO three times a day for 1 month and 1 ml in 3 divided doses for 2 months. The acute tolerability study on Day 1 was conducted in a Clinical Pharmacology daycare Unit. Blood pressure and pulse were recorded frequently on Day 1 and at 24, 48, 72 and 96 hours and fortnightly till 12 weeks. Volunteers were daily supervised for TO intake as well as for any side effects throughout the study period. RESULTS: Nine volunteers were enrolled for the study. One discontinued on 3rd day for allergic skin rashes which, on discontinuation of TO, gradually disappeared by two weeks. Another discontinued on 7th day for intercurrent fever requiring antibiotic treatment. Seven volunteers completed the study. There was no effect of TO, in two doses, on pulse and blood pressure and no side effects in acute tolerability study on Day 1. There was no effect of TO intake on weight, blood pressure, symptoms and signs upto 12 weeks. There was no clinical, haematological, renal or hepatic-toxicity of TO at 1 month and 3 months. Serum lipids did not show significant change except in one volunteer (reversible). CONCLUSIONS: In view of the potential for reversing oral submucous fibrosis, a precancerous condition for oral cancer, TO, can be recommended directly for a Phase II trial in patients.en_US
dc.description.affiliationBhavan's Swami Prakashananda Ayurveda Research Centre, 13th NS Road, Juhu, Mumbai 400 049.en_US
dc.identifier.citationJoshi J, Ghaisas S, Vaidya A, Vaidya R, Kamat DV, Bhagwat AN, Bhide S. Early human safety study of turmeric oil (Curcuma longa oil) administered orally in healthy volunteers. Journal of the Association of Physicians of India. 2003 Nov; 51(): 1055-60en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/87482
dc.language.isoengen_US
dc.source.urihttps://www.japi.orgen_US
dc.subject.meshAdulten_US
dc.subject.meshBlood Cells --drug effectsen_US
dc.subject.meshBlood Coagulation --drug effectsen_US
dc.subject.meshBlood Pressure --drug effectsen_US
dc.subject.meshChemopreventionen_US
dc.subject.meshCurcuma --adverse effectsen_US
dc.subject.meshFemaleen_US
dc.subject.meshHuman Experimentationen_US
dc.subject.meshHumansen_US
dc.subject.meshMedicine, Ayurvedicen_US
dc.subject.meshMouth Neoplasms --prevention & controlen_US
dc.subject.meshOral Submucous Fibrosis --prevention & controlen_US
dc.subject.meshPlant Extracts --adverse effectsen_US
dc.subject.meshSafetyen_US
dc.subject.meshTime Factorsen_US
dc.subject.meshWater-Electrolyte Balance --drug effectsen_US
dc.titleEarly human safety study of turmeric oil (Curcuma longa oil) administered orally in healthy volunteers.en_US
dc.typeClinical Trialen_US
dc.typeClinical Trial, Phase Ien_US
dc.typeJournal Articleen_US
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